Xatmep – The First and Only Ready-To-Use Methotrexate Oral Solution is Now Available

Xatmep – The First and Only Ready-To-Use Methotrexate Oral Solution is Now Available

Denver, July 31, 2017 — Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for children, today announced that Xatmep™ (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution, is now available for ordering. Xatmep is indicated for the treatment of acute lymphoblastic leukemia (ALL) and the management of polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients.“Xatmep is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of methotrexate for children without the need for needles, crushing of tablets, or compounding into a liquid formulation,” said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. “As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.”
Xatmep (methotrexate) Oral Solution, 2.5 mg/mL, is a ready-to-use product that requires no preparation, facilitating ease of dispensing at the pharmacy. Xatmep is manufactured under CGMPs in accordance with FDA regulations. It eliminates the need for needles, crushing or splitting tablets, or compounding tablets into a liquid formulation. It requires refrigeration, but may be stored at room temperature for 60 days after dispensing to the patient. Xatmep will be available through an extensive network of pharmacies. For additional information on how to obtain Xatmep, please call 1-855-379-0382.

INDICATIONS

XATMEP is a folate analog metabolic inhibitor indicated for the:

treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.

management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full-dose non-steroidal anti-inflammatory agents (NSAIDs).

About Xatmep

Xatmep (methotrexate) Oral Solution was developed, primarily, to meet the need for a ready-to-use, 2.5 mg/mL, methotrexate oral solution for the treatment of pediatric patients for the indications stated above. Prior to Xatmep, there was no FDA-approved, ready-to-use oral liquid formulation of methotrexate for use by pediatric patients requiring body surface-area (BSA) dosing (mg/m2), or those who have difficulty swallowing or cannot consume tablets, or those with a fear of needles/injections. Silvergate’s Xatmep resolves these unmet medical needs in pediatric patients.

Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated
in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing
XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive
potential to use effective contraception during and after treatment with XATMEP [see Contraindications
(4), Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3)].

ADDITIONAL IMPORTANT SAFETY INFORMATION

Contraindications:
Xatmep is contraindicated in pregnant patients with non-malignant disease and in patients with severe hypersensitivity to methotrexate.
Warnings and Precautions: See full Prescribing Information for additional information.

Secondary malignancies can occur at all dose levels. Lymphoproliferative disease has been reported with low-dose oral methotrexate which regressed when methotrexate is withdrawn.

Methotrexate can cause embryo-fetal toxicity and fetal death when administered during pregnancy. Consider the risks and benefits of Xatmep and risks to the fetus when prescribing to a pregnant patient with a neoplastic disease. Effective contraception should be practiced by patients of reproductive potential while receiving Xatmep therapy, and for 3 and 6 months afterwards for males and females, respectively. Xatmep is contraindicated in non-neoplastic disease.

Effects on reproduction: Methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. It is unknown if the infertility is reversible in affected patients.

Pulmonary function tests may be useful if methotrexate-induced lung disease is suspected, especially if baseline measurements are available.

Risk of improper dosing: Once-weekly dosing is appropriate. Fatal toxicity has been reported with daily dosing. An accurate milliliter measuring device should be used. Inform patients that a household teaspoon is not an accurate measuring device and could lead to overdosage.

Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance
to infection.

The approximate incidences of adverse reactions reported in pediatric patients with JIA treated with oral, weekly
doses of methotrexate (5 to 20 mg/m2/week or 0.1 to 0.65 mg/kg/week) were as follows (virtually all patients
were receiving concomitant nonsteroidal anti-inflammatory drugs, and some also were taking low doses of
corticosteroids): elevated liver function tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea),
11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; and rash, 0.2%. Although
there is experience with dosing up to 30 mg/m2/week in JIA, the published data for doses above 20 mg/m2/week
are too limited to provide reliable estimates of adverse reaction rates.

Drug Interactions:

Penicillins may reduce the clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with methotrexate. Monitor patients accordingly.

Keep this and all medications out of reach of children.To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383,
or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatchPlease see full Prescribing Information including BOXED WARNING.About Silvergate Pharmaceuticals, Inc.
Headquartered near Denver, Colorado, Silvergate Pharmaceuticals, Inc., is a privately held pharmaceutical company dedicated to leading the way in the development and commercialization of innovative pediatric medications that are safe, effective, and readily available.
Silvergate Pharmaceuticals is committed to filling the unmet needs of children, developing innovative medications that will help improve the quality of care and outcomes for pediatric patients. For more information, please visit www.Xatmep.com.
Reference: 1. Xatmep™ [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2017.
Contact
Silvergate Pharmaceuticals, Inc.
1-855-379-0382
silvergatepharma@silvergatepharma.com
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